SOP Solution

Business Needs

Regulations

Content in context to work

Compliance with Quality Guidelines

Features

FTE’s saved Improve in productivity Savings in paper elimination Savings on IT system TCO

XX X% XX € XX €

Return on Investment

“Efficient and compliant Standard Operating Procedure (SOP) management is essential for highly regulated industries to maintain the highest level of quality in every facet of their

operations, while at the same time reducing costs and maintaining margins”

Regulatory Compliance

• Automated version control

• Automated notification and distribution

• Automated review and approval

• Template management

• Content comparison

• Complies with FDA 21CFR Part 11 for electronic document management

Search Functionality

• Content and metadata search

• User defined saved searches

Security

• Role based access to content

• Auditability and traceability of the process

• Controlled printing

• Watermarking for managing hardcopies

The solution has 3 integrated modules

Added Value Apps

Lotus Notes Migration Tool

Validation Services

Training Certificate Report

Out of Office Report

Audit Trail Report

Integration with SAP BO

FABRICATION GUIDES

Integrated with SAP manufacturing process

Controlled printing of guides and master document

Change of state workflow

Deviation management

TRAINING

Integrated with SAP HR

Employee skill and work role Management

Register of SOP training

Management of External Training

Generation of Skills Certificate

SOP MANAGEMENT

Creation

Revision

Approval

Publishing and Distribution

Review

Archiving

Stratesys has developed a solution, aimed to:

• seamlessly comply with GxP and GMP practices

• simplify the process of SOP management

• automate the needed for review and approval

• keep all the content in a controlled and secure platform

• Manage security and content access based on standard business roles

• keep audit trail of all the SOP lifecycle

This solution:

• Ensures compliance

• Enhances efficiency reducing cost per SOP

• Boosts productivity

• Reduces IT TCO

• Comply with market regulations (i.e.: FDA)

• Optimize productivity

• Reduce operation costs

• Ensure quality of production

Stratesys SOP Solution brings together market best-practices and best of breed technology to automate and better monitor critical business processes for chemical, pharmaceutical, medical device and biotechnology industries. This modular solution covers the full SOP lifecycle from the creation to the employee training, allowing the QA department a 360º vision of the process within the organization.

SOP guidelines generally refer to a set of best practice guidelines that contribute to operate within the quality control and quality assurance goals and standards.

In R&D and manufacturing, Standard Operating Procedures (SOPs) define the business rules and processes for everything from pre-clinical research, clinical development, and equipment operation to the release of new products.

SOP Management enables an organization to:

SOP Management Process Flow

Edit

Create

Retire

Consume

Electronic Sign-off

Auto Promote

Review history

Controlled

Authorizer

Periodic Review

Archive

Initiate Create / Activate a Review

Collaborative Review

Revise

Review

Authorize

Workflow Coordinator

Editor

Approve

Consumer

Active Document Folder

Document previous versions

Current document with “Approved”

Status

Approving date assigned

Approver

Predefined Metadata

Watermark Controlled Printing

Predefined workflow

Predefined Document Templates

Predefined user roles

HR Integration

TRAINING MODULE

FABRICATION GUIDES

MODULE

We develop IT services implementing OpenText Solutions in several industries

Stratesys is also SAP Service Partner specialized in delivery services for the following SAP Solution Extensions by OpenText:

Our Par tnersh ip wi th OpenText

Stratesys is a Select Partner of OpenText, recognizing our position as experts in the delivery of OpenText enterprise information management solutions to its customers.

With this partnership, Stratesys is committed to maintaining up-to-date knowledge through on-going training, certification and blended delivery of services, as well as having our own “excellence center” to show customers the business benefits of these applications.

In Stratesys we have a deep understanding and wide experience in OpenText products that integrate with our clients SAP software landscape. Our expertise in design-definition, implementation and support, combined with a specific understanding of vertical market requirements, places Stratesys as one of the major players in project execution in this technology.

Core Services

Implementation

AM Document Analysis

Change Management

Model Definition

Public Sector, Health & Education

Telecom & Media

Manufacturing

Construction & Real Estate

Energy & Uti l it ies

Retail

Transportation

Life Sciences

Banking & Insurance

Consume Goods

SAP Document Access by OpenText

SAP Extended ECM by OpenText

SAP Digital Asset Management by

OpenText

SAP Document Presentment by OpenText

SAP Invoice Management by OpenText

OCR Option for SAP Invoice Management by OpenText SAP Employee File

Management by OpenText SAP Archiving by OpenText

Copyright Stratesys Technology Solutions SL. All rights reserved.

No part of this document may be reproduced or transmitted by any means, for any purpose without the express

permission of Stratesys. All products are trademarks or registered trademarks of their respective companies.

info@stratesys-ts.com

B R A Z I L | C H I N A | C O L O M B I A | M E X I C O | P O R T U G A L | S P A I N | U S A

www.stratesys-ts.com @stratesys

With the Partner Program for SAP Competence, OpenText

relies on partners that clearly differentiate themselves

through deep technical SAP expertise from other service

providers and consulting firms in the market. Being a SAP

Competence partner certifies Stratesys as a highly

committed, innovative, and growth-oriented company with

excellent project, industry, and process knowledge.

FRV

Click on the pictures to learn more about our OpenText customer success stories

COBEGA

Leaders in SAP & OpenText Technology Innovators and Specialists